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NCT02420795 · ADVERSE EVENTS

Adverse events

Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma · Source last updated 2022-04-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
From the first dose through every 3 months after the last dose of study medication, up to 1 year.
Other-event reporting threshold
1%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
ONC201 125 mg

Patients receive Akt/ERK inhibitor ONC201 125 mg PO on day 1 of every cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

0 / 44 / 40 / 4
ONC201 250 mg

Patients receive Akt/ERK inhibitor ONC201 250 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

1 / 22 / 20 / 2
ONC201 625 mg

Patients receive Akt/ERK inhibitor ONC201 625 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

1 / 55 / 51 / 5

Group identifiers: EG000: ONC201 125 mg · EG001: ONC201 250 mg · EG002: ONC201 625 mg

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Dehydration
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Blood and lymphatic system disorders- Other
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Myocardial Infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Edema Limbs

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    term
    Anxiety
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Appetite change
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    AST increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Back pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Blood and lymphatic system disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Blurred vision
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Bug bites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    BUN increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Cough
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Patients receive Akt/ERK inhibitor ONC201 125 mg PO on day 1 of every cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    ONC201 125 mg
  2. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Patients receive Akt/ERK inhibitor ONC201 250 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    ONC201 250 mg
  3. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    Patients receive Akt/ERK inhibitor ONC201 625 mg PO every 7 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    ONC201 625 mg
frequency Threshold
1
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    term
    Anxiety
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Appetite change
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    AST increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Back pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Blood and lymphatic system disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Blurred vision
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Bug bites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    BUN increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Cough
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Dehydration
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Blood and lymphatic system disorders- Other
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Myocardial Infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (12)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Edema Limbs
time Frame
From the first dose through every 3 months after the last dose of study medication, up to 1 year.

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